GSK kick-starts phase 3 Medicago-partnered COVID vaccine test

GlaxoSmithKline and Sanofi tripped up in a recent COVID-19 vaccine test, but the U.K. Big Pharma is hoping for better luck with its second partner Medicago.

The pair penned a vaccine deal last summer, wedding Canada-based Medicago’s recombinant coronavirus viruslike particles (CoVLPs) with GSK’s pandemic adjuvant system, which has been used in previous epidemics.

A similar vaccine approach didn’t initially work out too well for Sanofi and GlaxoSmithKline, which late last year posted weak results in older patients using their adjuvanted recombinant protein-based COVID-19 vaccine candidate. A month ago, after tweaking the vaccine, the pair began a phase 2 clinical trial of a new version of the vaccine.

Presumably learning from this, GSK is also now moving into a phase 3 with Medicago, using the FDA fast-tracked vaccine in about 30,000 patients while also assessing the shot “to address emerging variants” in a feasibility test. The trial is part of the ongoing phase 2/3 study started last November.

As part of the program, patients in the trial will get two doses of 3.75 micrograms of CoVLPs administered 21 days apart. This new trial is an event-driven, randomized, observer-blinded, placebo-controlled, two-way crossover design that will look at the efficacy and safety of the adjuvanted CoVLP formulation compared to placebo.

The 30,000 subjects will at first be made up of healthy adults (18 to 65 years old), followed by elderly adults (65 years old-plus) and adults with comorbidities. It will also “enroll males and females from ethnically and racially diverse populations,” although it did not give a breakdown of the numbers here.

The phase 2 part of the trial should see early data out next month, GSK confirmed in its statement.

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While behind the likes of Pfizer-BioNTech, Moderna, Johnson & Johnson and AstraZeneca-Oxford University, Russia’s Sputnik V and several Chinese biotech vaccines—all of which have various emergency authorizations—GSK still has a big role to play given the major need for more vaccines, especially those against new variants, and having another shot which can be stored and moved more easily than the current crop of mRNA vaccines.

GSK and Medicago have previously said they foresee making their vaccine available for mid-2021.